Regulatory Specialist (Medical Devices)

Location: Hybrid role based in Warsaw, Masovian, Poland

Base pay: PLN 145,800–234,600 annually

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions, with DePuy Synthes focused on orthopaedics.

What you will do

• Manage regulatory compliance and clearance activities for medical devices distributed across the CEE Central Region.
• Coordinate product notifications, submissions, system updates, and regulatory database maintenance.
• Review copy materials and provide regulatory support to business, tender, reimbursement, distributor, and franchise partners.
• Deliver regulatory affairs training to local clusters and communicate compliance updates, risks, and issues to management.
• Monitor legislation, lead compliance projects, and ensure regulatory SOPs are updated and followed.
• Support internal and external audits, quality management system deployments, document changes, and regulatory restriction-removal processes.

Requirements

• At least 2 years of experience in a Regulatory Affairs environment.
• Knowledge of regulatory requirements and the medical devices environment.
• Polish and English are required.
• Strong communication, interpersonal, organizational, planning, and attention-to-detail skills.
• Advanced knowledge of Microsoft Word, Excel, and related functions.
• Ability to understand cross-enterprise data flows and systems and collaborate with internal and external stakeholders.

Nice to have

• Additional CEE language skills.
• Experience with regulatory compliance, risk assessments, product licensing, and medical device development and regulation.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, and equal opportunity.
• Annual performance-based bonus or sales commissions, depending on the position and location.
• Vacation, parental, bereavement, caregiver, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Insurance plans, service anniversary awards, and recognition programs, subject to applicable plan terms.